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Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism (LIPOTAR-07)

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ClinicalTrials.gov Identifier: NCT00759070
Recruitment Status : Unknown
Verified February 2013 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : February 22, 2013
Sponsor:
Collaborators:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Hospital Universitari Joan XXIII de Tarragona.
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE September 23, 2008
First Posted Date  ICMJE September 25, 2008
Last Update Posted Date February 22, 2013
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2008)
Changes in total cholesterol and HDL and LDL fractions [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Official Title  ICMJE Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Brief Summary This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Tenofovir + emtricitabine + efavirenz

    Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)

    + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily

  • Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
    Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID
Study Arms  ICMJE
  • Active Comparator: 1
    Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
    Intervention: Drug: Tenofovir + emtricitabine + efavirenz
  • Active Comparator: 2
    Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
    Intervention: Drug: Tenofovir + emtricitabine + lopinavir/ritonavir
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 23, 2008)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic HIV-1 infection
  • Age 18 or above
  • Antiretroviral-naive
  • Criteria for antiretroviral therapy in accordance with current guidelines
  • Plasma LDL-cholesterol below 190 mg/dL
  • Not receiving lipid-lowering agents
  • Written informed consent

Exclusion Criteria:

  • Use of phytosterol-enriched food previous month.
  • Pregnancy or breastfeeding
  • Cardiovascular disease
  • Secondary Hypercholesterolemia
  • Plasma creatinine above 1,2 mg/dL)
  • Aminotransferases above 5 times ULN
  • Current treatment for hepatitis C coinfection
  • Diabetes mellitus (fasting glycemia > 124 mg/dL)
  • Illegal drug use or alcohol abuse
  • Active AIDS-defining opportunistic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759070
Other Study ID Numbers  ICMJE LIPOTAR-07
EudraCT number: 2007-002698-29
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan A. Arnaiz, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Juan A. Arnaiz
Collaborators  ICMJE
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Germans Trias i Pujol Hospital
  • Hospital Universitari Joan XXIII de Tarragona.
  • Hospitales Universitarios Virgen del Rocío
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP